Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ultrasound-guided suction, Continuous subglottic suction, Intermittent subglottic suction.
- Who it may be relevant to
- Registry conditions: Ultrasound Guidance, Subglottic Airway Injury, Airway Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Subglottic suctioning, as an important airway management technique, has its operational accuracy and safety directly impacting patient prognosis. Therefore, improving the effectiveness and safety of subglottic suctioning has become a focus of clinical attention. Point-of-care ultrasound, which can provide imaging, can be used to guide subglottic suctioning, enhancing the intuitiveness of the procedure. This study aims to evaluate the safety and effectiveness of subglottic suctioning guided by point-of-care ultrasound in mechanically ventilated patients, in order to help standardize clinical practice and improve medical quality.
Interventions
- Other ultrasound-guided suction
In accordance with the recommended timing for subglottic suctioning as outlined in 'Operational Guidelines for Subglottic Suctioning under Artificial Airway', subglottic suctioning is performed under ultrasound imaging guidance. Based on semi-quantitative assessment of secretions via ultrasound airway examination, suctioning is administered if the score is ≥1. After suctioning is completed, ultrasound re-evaluation is conducted, and the procedure continues until the score equals 0, at which poin - Other Continuous subglottic suction
Provide continuous subglottic suction for 24 hours by connecting to a central negative pressure device, using constant negative pressure for continuous suction. The suction pressure is maintained at: 40\~60 mmHg. - Other Intermittent subglottic suction
Suction time is the same as that of the ultrasound-guided group. The device uses a bedside wall-mounted negative pressure suction apparatus, with the suction pressure maintained at 100 \~ 150 mmHg (1 mmHg = 0.133 Kpa). The operation is ended based on the operator's experience.
Primary outcome measures
- Incidence of ventilator-associated pneumonia (VAP) [Time frame: Daily assessment from randomization up to 7 days.]
Secondary outcome measures (6)
- Positive rate of occult blood in airway mucosa [Time frame: Daily assessment from randomization up to 7 days.]
- Incidence of airway mucosal injury [Time frame: Daily assessment from randomization up to 7 days.]
- Mechanical ventilation duration [Time frame: Daily assessment from randomization up to 28 days.]
- ICU Length of Stay [Time frame: Daily assessment from randomization up to 28 days.]
- 28-day Mortality Rate [Time frame: Daily assessment from randomization up to 28 days.]
- Aspiration incidence rate [Time frame: Daily assessment from randomization up to 7 days.]
Eligibility criteria
Inclusion criteria
- 1\. Patients admitted to the ICU with the patient or their legal representative having signed an informed consent form; 2. Patients expected to have an oral artificial airway in place for ≥72 hours; 3. Patients using tracheostomy tubes with subglottic suctioning
Exclusion criteria
- 1\) Severe cervical deformity, extensive subcutaneous emphysema, thick dressing coverage, or severe obesity that prevents clear visualization of the subglottic region by ultrasound.
2\) Coagulopathy (platelets <50×10⁹/L) or active bleeding tendency, which may induce airway bleeding due to suctioning procedures.
3\) Presence of organic airway disease or previous cervical surgery history, affecting assessment of the subglottic region.
4\) Tracheostomy patients. 5) Patients allergic to ultrasound coupling agents, or those unable to cooperate with cervical ultrasound examination due to severe agitation.
6\) Patients with existing pulmonary infection upon admission. 7) Patients intubated for treatment of known aspiration. 8) History of lung cancer or head and neck cancer that may produce alpha-amylase in the lungs.
9\) History of conditions affecting salivary secretion (e.g., Sjögren's syndrome).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07496385 · ZWQ21886-2026-EC-